Effects of Genuine vs Sham Acupuncture and Communication Type on Relaxation (ACU)

Karolinska Institute

Status and phase: Completed; Phase 4

Conditions: Healthy

Treatments: Procedure: neutral communication; Procedure: sham acupuncture; Procedure: acupuncture; Procedure: positive communication

Study type: Interventional

Funder types: Other

Identifiers

NCT02525445

ACU 2013/80-31

Details and patient eligibility

About

The purpose of this study is to investigate if it is possible to influence the participants' expectations to improve outcome, in this particular setting the relaxing effects of one single acupuncture treatment with genuine or sham needles combined with positive or neutral communication regarding expected relaxing effects.

Full description

Background It is commonly reported that individuals experience a sense of relaxation during acupuncture treatment. However it is not known if the effects are related to the specific effects of needling or non-specific effects associated with the treatment procedure e.g. the communication with the therapist. It is well known that the way in which patients and clinicians communicate with each other affect treatment outcome, and one of the possible mechanisms to mediate the communication-related treatment outcomes is patient expectations.

Aims The aim of the study is therefore to investigate if it is possible to influence the individuals' expectations to improve outcome; in this particular setting the relaxing effects of one single acupuncture treatment with genuine or sham needles combined with positive or neutral communication regarding expected relaxing effects. The investigators also aim to investigate if different therapists influence how individuals perceive treatment effects, blinding and the communication during treatment with genuine and sham acupuncture.

Procedure Nine therapists performed treatments on voluntary healthy individuals who were randomized to a 30 minute treatment session with a) genuine penetrating acupuncture in traditional acupuncture points or b) non-penetrating sham needles in sham points. Within groups, individuals were further randomized to two communication styles 1) neutral communication or 2) strengthened positive communication regarding expectations concerning relaxing effects.

Outcome measures Perceived degree of expectancy and relaxation was measured directly before and after the treatment. The individuals also rated how they experienced the therapist´s communication style regarding grade of positivity and if they believed that the therapist had given them genuine or sham acupuncture directly after treatment.

Enrollment: 243 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Over 18 years of age
• Able to understand and read/write Swedish

Exclusion criteria

• No acupuncture training

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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243 participants in 4 patient groups

acupuncture positive communication

Active Comparator group

Description:

Genuine acupuncture needles combined with positive communication regarding the expected treatment effects

Treatment:

Procedure: positive communication

Procedure: acupuncture

sham acupuncture positive communication

Sham Comparator group

Description:

Sham acupuncture needles combined with positive communication regarding the expected treatment effects

Treatment:

Procedure: positive communication

Procedure: sham acupuncture

acupuncture neutral communication

Active Comparator group

Description:

Genuine acupuncture needles combined with neutral communication regarding the expected treatment effects

Treatment:

Procedure: acupuncture

Procedure: neutral communication

sham acupuncture neutral communication

Sham Comparator group

Description:

Sham acupuncture needles combined with neutral communication regarding the expected treatment effects

Treatment:

Procedure: neutral communication

Procedure: sham acupuncture